Written by experts in the field of pharmacovigilance and patient safety, this concise resource provides a succinct, easy-to-digest overview of an increasingly critical area of medical safety. Drs. Thao Doan, Cheryl Renz, Fabio Lievano, Mondira Bhattacharya, and Linda Scarazzini provide essential information for health care professionals, clinical researchers, and regulators who need a comprehensive, up-to-date source of information on the principles and practice of pharmacovigilance.
1. Introduction - p. xi 2. Section I. The Regulatory Environment - p. xi 3. Chapter 1. Does Regulation Drive Science or Does Science Drive Regulation? - p. 1 4. Section II. Safety Data And Real World Evidence - p. 11 5. Chapter 2. Signal Management and Methods of Signal Detection - p. 13 6. Chapter 3. Product Safety Monitoring in Clinical Trials - p. 31 7. Chapter 4. Causality Assessment and Examples of Adverse Drug Reactions (Drug-Induced Liver Injury, Renal, Skin, and Major Adverse Cardiac Events) - p. 47 8. Chapter 5. Role of Epidemiology in the Biopharmaceutical Industry - p. 69 9. Chapter 6. Real-World Epidemiologic Studies and Patient Registries - p. 89 10. Section III. Special Topics and Special Populations - p. 100 11. Chapter 7. Vaccine Pharmacovigilance - p. 101 12. Chapter 8. Pharmacovigilance in Pregnancy - p. 113 13. Chapter 9. Pharmacovigilance in Pediatrics - p. 129 14. Chapter 10. Pharmacovigilance in Special Populations: Elderly - p. 137 15. Chapter 11. Medical Device Vigilance and Postmarket Surveillance - p. 145 16. Chapter 12. Application of Human Factors and Health Literacy in Pharmacovigilance - p. 155 17. Section IV. The Next Frontier - p. 159 18. Chapter 13. Benefit-Risk Management - p. 161 19. Chapter 14. Information Technology in Pharmacovigilance: Current State and Future Directions - p. 181 20. Chapter 15. The Future of Safety Science - p. 197 21. Index - p. 205
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Written by experts in the field of pharmacovigilance and patient safety, this concise resource provides a succinct, easy-to-digest overview of an increasingly critical area of medical safety. Drs. Thao Doan, Cheryl Renz, Fabio Lievano, Mondira Bhattacharya, and Linda Scarazzini provide essential information for health care professionals, clinical researchers, and regulators who need a comprehensive, up-to-date source of information on the principles and practice of pharmacovigilance.
1. Introduction - p. xi 2. Section I. The Regulatory Environment - p. xi 3. Chapter 1. Does Regulation Drive Science or Does Science Drive Regulation? - p. 1 4. Section II. Safety Data And Real World Evidence - p. 11 5. Chapter 2. Signal Management and Methods of Signal Detection - p. 13 6. Chapter 3. Product Safety Monitoring in Clinical Trials - p. 31 7. Chapter 4. Causality Assessment and Examples of Adverse Drug Reactions (Drug-Induced Liver Injury, Renal, Skin, and Major Adverse Cardiac Events) - p. 47 8. Chapter 5. Role of Epidemiology in the Biopharmaceutical Industry - p. 69 9. Chapter 6. Real-World Epidemiologic Studies and Patient Registries - p. 89 10. Section III. Special Topics and Special Populations - p. 100 11. Chapter 7. Vaccine Pharmacovigilance - p. 101 12. Chapter 8. Pharmacovigilance in Pregnancy - p. 113 13. Chapter 9. Pharmacovigilance in Pediatrics - p. 129 14. Chapter 10. Pharmacovigilance in Special Populations: Elderly - p. 137 15. Chapter 11. Medical Device Vigilance and Postmarket Surveillance - p. 145 16. Chapter 12. Application of Human Factors and Health Literacy in Pharmacovigilance - p. 155 17. Section IV. The Next Frontier - p. 159 18. Chapter 13. Benefit-Risk Management - p. 161 19. Chapter 14. Information Technology in Pharmacovigilance: Current State and Future Directions - p. 181 20. Chapter 15. The Future of Safety Science - p. 197 21. Index - p. 205
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